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| CLINICAL DEVELOPMENT PIPELINE | |
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HGS has a well balanced and deep portfolio of novel drugs directed toward diseases that represent significant unmet medical need. Three of these products are in late-stage development. BENLYSTA™ (belimumab) has successfully met its primary endpoint in two pivotal Phase 3 trials in systemic lupus, and we expect the submission of marketing applications in the United States, Europe and other regions in the first half of 2010. ZALBIN™ (albinterferon alfa-2b) has completed Phase 3 development in chronic hepatitis C, and we expect the submission of global marketing applications in fourth quarter 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. In May, we submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. The FDA has notified us that our BLA has been filed and will receive priority review.
Right behind these late-stage products is an emerging high-potential mid-stage pipeline, led by our anti-cancer products, HGS-ETR1 (mapatumumab) and HGS 1029, an IAP inhibitor – both for the treatment of cancer. We also have substantial financial rights to a number of products in the GlaxoSmithKline clinical pipeline. GSK has initiated Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease, and Syncria® (albiglutide) in patients with type 2 diabetes mellitus.
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